Method for puncturing the pericardial membrane by synchronizing needle advancement with cardiac muscle motion

ABSTRACT

A method for puncturing a pericardial membrane of a human patient, the method comprising inserting a needle into the chest of the human patient, detecting a phase of a mechanical activity of the heart of the human patient, advancing the needle toward the heart of the human patient in synchronization with the detected phase of the mechanical activity of the heart of the human patient, and repeating the detecting and advancing steps until the pericardial membrane of the human patient is punctured.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 13/625,498, filedSep. 24, 2012, now U.S. Pat. No. 8,834,506, which contains subjectmatter related to that described in commonly owned U.S. patentapplication Ser. No. 13/943,542, titled “A Pericardial Needle forPhysically Separating and Penetrating Pericardial Heart Tissue”,inventor “Fawaz Alhumaid”, and incorporated herein by reference in itsentirety.

The present application contains subject matter related to thatdescribed in commonly owned U.S. patent application Ser. No. 14/224,245,now U.S. Pat. No. 9,517,102, titled “A Pericardial Needle for CauterallySeparating and Penetrating Pericardial Heart Tissue”, inventor “FawazAlhumaid”, and incorporated herein by reference in its entirety.

GRANT OF NON-EXCLUSIVE RIGHT

This application was prepared with financial support from the SaudiArabian Cultural Mission, and in consideration therefore the presentinventor has granted The Kingdom of Saudi Arabia a non-exclusive rightto practice the present invention.

BACKGROUND

Field of the Disclosure

This invention relates to a method for puncturing the pericardialmembrane. More specifically, this invention relates to a method forpuncturing the pericardial membrane by synchronizing needle advancementwith cardiac muscle motion.

Description of the Related Art

The “background” description provided herein is for the purpose ofgenerally presenting the context of the disclosure. Work of thepresently named inventor, to the extent it is described in thisbackground section, as well as aspects of the description which may nototherwise qualify as prior art at the time of filing, are neitherexpressly nor impliedly admitted as prior art against the presentinvention.

As cardiac medical care advances, there is an increasing number oftherapeutic procedures that require access into the pericardial space.Examples of such procedures are those needed for pacemakers,defibrillators, and ablation of certain arrhythmias. The pericardialspace is a virtual space between the outside of the heart muscle and athin layer of tissue that encases the heart muscle, called the parietalpericardium. The pericardial space contains a small amount of fluid,called the pericardial fluid.

The pericardial fluid is in constant contact with the heart muscle andthe coronary arteries, and therefore, may be used to deliver drugs tothe heart muscle and/or the coronary arteries. Since the pericardialfluid is of relatively low volume, such method of drug delivery requiresa relatively lower dose of drug.

Additionally, the pericardial fluid may be used to introduce an agentinto the pericardial space, while localizing the agent to the areaaround the heart muscle. Such agent is contained within the pericardialfluid, without contaminating other tissue or parts. Also, due to the lowturn over rate of the pericardial fluid, such agent is sustained over arelatively long period of time.

Conventionally, and as shown in FIGS. 1A-1C, there are two commonlyaccepted locations on the chest that may be used for the insertion ofthe needle 107 to access the pericardial space 105: subxiphoid (FIGS. 1Aand 1C) and apical (FIG. 1B). Although the apical location correspondsto a lower risk of damaging extracardiac structures, as not many existin the needle's path, it is generally avoided due to the presence of amajor coronary artery (the Left Anterior Decending coronary artery) inthe area where the puncture occurs, and hence the associated risk ofpuncturing that artery and causing a heart attack. Access into thepericardial space 105 is attained with a blunt tip needle 107 adoptedfrom the field of anesthesia, called the Tuohy needle. The Tuohy needleis an epidural introducer needle. To use the subxiphoid location toaccess the pericardial space 105 between the heart muscle 101 and theparietal pericardium 103, the needle 107 is carefully inserted betweenthe Xiphoid process 109 and the diaphragm 111, and advanced toward theheart muscle 101 in order to penetrate the parietal pericardium 103without damaging or penetrating the heart muscle 101.

Multiple advancements of the needle, with gradual increase in pressureapplied to the parietal pericardium 103 may be required until it ispunctured. In order to determine if/when the parietal pericardium 107 ispunctured, test injections of a contrast agent may be done followingeach advancement. Once the parietal pericardium 107 is punctured, thecontrast agent can be seen filling the pericardial space 105. At thispoint, no additional punctures are done.

With the exception of patients with a pericardial effusion (a largeamount of fluid collection in the pericardial space due to bleeding orother disease process), the process of accessing the pericardial space105 is a difficult one with a relatively high complication rate due tothe small space between the parietal pericardium 103 and the heartmuscle 101 (few millimeters at most) and the continuous motion of theheart before, during, and after puncturing the parietal pericardium 107.

In some cases, the needle tip may penetrate the heart muscle 101,creating a leak of blood from the inside of the heart into thepericardial space 105. Such leak can lead to tamponade and hypotension.In other cases, the needle tip may damage a coronary artery (arteriesthat supply the heart muscle with oxygen and nutrients), which can causea heart attack. Such complications are life-threatening if not quicklyand properly addressed.

Other possible risks include damage to extracardiac structures that arepresent in the needle's path. For example, the needle may puncture thestomach, colon, liver, or diaphragm. It may also lacerate an arterycausing significant bleeding. Such complications are serious, andpotentially life-threatening.

SUMMARY

This disclosure relates to a method for puncturing a pericardialmembrane.

In one aspect of the invention, there is provided a method that includespuncturing a pericardial membrane by synchronizing needle advancementwith cardiac muscle motion, minimizing the potential for damage to theheart muscle.

In one aspect of the invention, there is provided a method withoutinvasive surgery that includes puncturing a pericardial membrane bysynchronizing needle advance with cardiac muscle motion, while avoidingthe damaging of the heart muscle.

In another aspect of the invention, there is provided a method thatincludes puncturing a pericardial membrane by synchronizing needleadvance with the cardiac systolic motion, while avoiding the damaging ofthe heart muscle.

In another aspect of the invention, there is provided a method thatincludes puncturing a pericardial membrane by synchronizing needleadvancement with the movement of the heart based on a phase of anelectrocardiogram, while avoiding the damaging of the heart muscle.

In another aspect of the invention, there is provided a method thatincludes puncturing a pericardial membrane by synchronizing needleadvancement with the movement of the heart based on the detection of aQRS complex within an electrocardiogram, while avoiding the damaging ofthe heart muscle.

In another aspect of the invention, there is provided a method thatincludes puncturing a pericardial membrane by synchronizing needleadvancement with the movement of the heart based on a pressure detectedat the tip of a needle used for puncturing the pericardial membrane,while avoiding the damaging of the heart muscle.

In another aspect of the invention, there is provided a method thatincludes puncturing a pericardial membrane by synchronizing needleadvancement with the movement of the heart based on an arterial pressuremeasurement, while avoiding the damaging of the heart muscle.

In another aspect of the invention, there is provided a method thatincludes puncturing a pericardial membrane by, for example, a physical,cautery, radio frequency, or a laser needle, by synchronizing needleadvancement with the movement of the heart, while avoiding the damagingof the heart muscle.

In another aspect of the invention, there is provided a method thatincludes puncturing a pericardial membrane by synchronizing needleadvancement with the movement of the heart, while avoiding the damagingof the heart muscle, and monitoring a contrast agent injected via aneedle used for puncturing the pericardial membrane to detect when thepericardial membrane is punctured.

The disclosed methods make accessing the pericardial space easier andsafer by utilizing the cardiac motion to puncture the parietalpericardium in synchronization with that motion.

The disclosed methods may be used to access the pericardial space inorder to deliver drugs to the heart muscle and/or the coronary arteries.Since the pericardial fluid is of relatively low volume, deliveringdrugs via the pericardial fluid requires a relatively lower dose ofdrug.

The disclosed methods may be used to access the pericardial space inorder to introduce an agent into the pericardial space, therebylocalizing the agent to the area around the heart muscle. Such agent isthereby contained within the pericardial fluid, without contaminatingother tissue and/or space. Also, due to the low turn over rate of thepericardial fluid, such agent is sustained over a longer period of time.

The disclosed methods may be used to access the pericardial space inorder to insert a catheter to deliver drugs and/or agents.

The disclosed methods may be used to access the pericardial space inorder to insert a catheter to collect biological tissue or cells.

The disclosed methods may be used to access the pericardial space inorder to insert a catheter into a specific area of the heart to performablation of arrhythmia. Ablation of arrhythmia is performed by directingenergy through a catheter to small areas of the heart muscle that causeor participate in abnormal heart rhythm, to eliminate the source of suchabnormal rhythm. This process may also be used to disconnect an abnormalelectrical pathway between the atria and the ventricles.

The disclosed methods may be used to access the pericardial space inorder to insert a catheter or tool to ligate the left atrial appendage.

The disclosed methods may be used to access the pericardial space, insituations where a cardiac procedure has led to bleeding into thepericardial space, to insert a catheter to drain blood from thepericardial space until the bleeding source seals on its own, or until asurgical procedure is done to repair it.

The disclosed methods may be used to access the pericardial space, insituations where a disease process has led to the accumulation of bloodor other types of fluid in the pericardial space, to insert a catheterto drain this fluid for diagnostic purposes, and/or to relieve thepressure exerted on the heart and improve its function.

The disclosed methods may be used to access the pericardial space, inorder to introduce implantable defibrillator and/or pacemaker electrodesinto the pericardial space.

The disclosed methods may be used under fluoroscopy guidance (X Ray),ultrasound, or CT scan.

The disclosed methods may also be used under magnetic resonance imagingwhen a non-metal needle is used.

The foregoing paragraphs have been provided by way of generalintroduction, and are not intended to limit the scope of the followingclaims. The described embodiments, together with further advantages,will be best understood by reference to the following detaileddescription taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the disclosure and many of the attendantadvantages thereof will be readily obtained as the same becomes betterunderstood by reference to the following detailed description whenconsidered in connection with the accompanying drawings, wherein:

FIGS. 1A-1C are illustrations of methods of accessing the pericardialspace;

FIGS. 2A and 2B are illustrative views of a process of accessing thepericardial space when the heart is in systole and diastole,respectively;

FIG. 3 is a graph of an electrocardiogram;

FIG. 4 is a flowchart for an embodiment of a method of synchronizing theprocess of accessing the pericardial space with the heart's systole;

FIG. 5 is a flowchart for an embodiment of a method of detecting systolebased on an electrocardiogram;

FIG. 6 is a flowchart for an embodiment of a method of detecting systolebased on a pressure measurement at the tip of a needle;

FIG. 7 is a flowchart for an embodiment of a method of detecting systolebased on arterial pressure measurement; and

FIG. 8 is a block diagram of a controller.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Referring now to the drawings, wherein like reference numerals designateidentical or corresponding parts throughout the several views, FIGS. 2Aand 2B are illustrative views of a process of accessing the pericardialspace 105 when the heart is in systole and diastole, respectively. Theheart muscle 101 is in continuous motion. This motion is periodic and iscalled the cardiac cycle. The cardiac cycle is composed of two mainphases called systole and diastole. Systole is the phase where theventricles contract, causing the heart to eject blood out of its innercavities. Diastole is the relaxation phase during which the ventriclesrelax and fill with blood.

As the needle 107 advances towards the pericardial space 105, the motionof the heart muscle 101 (the ventricles) has significant impact on theability to achieve the goal of penetrating one layer (the parietalpericardium 103), without penetrating or damaging the adjacent movingheart muscle 101.

The inventor of the present disclosure identified that the risk ofinadvertently penetrating the heart muscle 101 is significantly lower ifthe penetration of the parietal pericardium 103 is synchronized withsystole. This is due to the fact that the heart muscle 101 is movingaway from the needle 107 during systole, and as shown in FIG. 2B. Thus,the disclosed methods of the present disclosure take advantage of themotion of the heart muscle 101, and change this motion from a factorthat adds to the risk of the procedure, to one that helps attain saferaccess to the pericardial space 105.

The parietal pericardium 103 encases the heart muscle 101. The distancebetween the parietal pericardium 103 and the outer layer of theventricles (the visceral pericardium) changes slightly as the heartmuscle 101 moves. This change in the distance between the parietalpericardium 103 and the ventricles provides a time window of opportunityfor safer access to the pericardial space 105, when such access issynchronized with the movement of the heart muscle 101.

According to an embodiment of the present disclosure, accessing thepericardial space 105 may be achieved by advancing through the parietalpericardium 103 in brief pulses, and synchronizing these pulses tosystole where the ventricles contract, thereby moving away from theneedle 107, relax, thereby moving towards the needle 107, and/or restand is in a static condition.

According to an embodiment of the present disclosure, accessing thepericardial space 105 may be achieved by inserting a needle between theribs at the left side of the chest. Even though important coronaryarteries may exists in such location, the associated risk ofinadvertently puncturing a coronary artery is reduced due to thesynchronization of the needle advancement with the movement of the heartmuscle 101, thereby making this location a viable option to be used inthe process of accessing the pericardial space 105.

In order to detect and synchronize with systole, visual, mechanical,electrical, or any other measurement indicative and/or predictive ofsystole, diastole and/or the heart condition may be utilized.

According to an embodiment of the present disclosure, an echocardiogrammay be used by a physician performing the process, to visually monitorthe motion of the cardiac muscle.

According to another embodiment of the present disclosure, anelectrocardiogram (ECG) may be utilized to indicate the phase of thecardiac cycle, and synchronize with systole. FIG. 3 is a graph of anECG. ECG is a recording of the electrical activity of the heart. Atypical ECG of the cardiac cycle (one heartbeat) consists of a P-wave, aQRS complex, and a T-wave. The P-wave reflects the atrial activation.The QRS complex reflects the ventricular activation, which is theelectrical activity that causes the ventricular heart muscle tocontract. Accordingly, the actual systolic mechanical motion of theventricles shortly follows the onset of the QRS complex shown in the ECGin FIG. 3.

Typically, mechanical systole starts approximately 30-40 millisecondsafter the onset of the QRS waveform (e.g., beginning of the Q wave), andlasts for approximately 300-350 milliseconds at resting heart rate innormal hearts. The duration of systole and the time between the onset ofthe QRS waveform and the beginning of systole may be altered by theheart rate, age, gender, body mass index (BMI), and/or the presence andnature of underlying heart disease in a human patient.

According to an embodiment of the present disclosure, the needle 107 maybe advanced preferably any time after the beginning and before the endof systole. According to an embodiment, the needle 107 may be advancedin a time window of 310 milliseconds, starting at 40 milliseconds afterthe onset of the QRS waveform and ending at 350 milliseconds after theonset of the QRS waveform.

According to another embodiment of the present disclosure, the timewindow allowed for needle advancement may be adjusted based on one ormore of many contributing factors including the heart rate, age, gender,and BMI of a human patient, in addition to the presence and nature ofunderlying heart disease. Such adjustment may be in terms of apercentage of the time window. Such adjustment may be manually performedby the physician performing the process of puncturing the parietalpericardium 103, or may be automatically performed by a controller. Labtesting may be used to search for the best time interval during thecardiac cycle and/or during systole.

FIG. 4 is a flowchart for an embodiment of a method of synchronizing theprocess of accessing the pericardial space 105 with the heart's systole.

In step S401, the process determines whether an instruction forinitiation of the process has been given. For example, a start buttonmay be pressed by a physician, indicating the initiation of the processof accessing the pericardial space 105. If no indication of initiationhas been detected, the process loops back to step S401. Otherwise, theprocess proceeds to step S403.

In step S403, the process checks if systole is detected. Detection ofsystole may be according to visual, mechanical, electrical, or any othermeasurement indicative of systole. If systole is not detected, theprocess loops back to step S403. Otherwise, the process proceeds to stepS405.

In step S405, the needle 107 is enabled and a timer is started.

According to an embodiment, a cautery needle, previously held in adisabled state, may be enabled in step S405, such that the cauteryneedle punctures the parietal pericardium 103 when cautery is enabled.

According to another embodiment, a needle blade, previously held in asecured state, may be released in step S405, such that the needle bladepunctures the parietal pericardium 103 when released.

According to another embodiment, a laser needle, previously held in aninactive state, may be activated in step S405, such that the laserneedle punctures the parietal pericardium 103 when activated.

In step S407, the process checks if the timer has exceeded apredetermined threshold. The predetermined threshold may be setaccording to an estimate of the duration of systole. If the timer hasnot exceeded a predetermined threshold, the process loops back to stepS407. Otherwise, the process proceeds to step S409.

In step S409, the needle 107 is disabled and the timer is stopped.

According to an embodiment, a cautery needle is disabled in step S409,such that cautery is no longer deliverable, so that the needle does notpunctures the parietal pericardium 103 when disabled.

According to another embodiment, a needle blade is secured in step S409,such that the needle blade does not puncture the parietal pericardium103 when secured.

According to another embodiment, a laser needle is de-activated in stepS409, such that the laser needle does not puncture the parietalpericardium 103 when de-activated.

In step S411, the process checks if an instruction to stop needleadvancement and/or stop the process has been received. For example, astop button may be pressed by a physician, indicating the success and/ortermination of the process of accessing the pericardial space 105. Ifthe process has not been interrupted, the process loops back to stepS403. Otherwise, the process exits in step S413.

Multiple advancement toward the parietal pericardium 103 may be neededin order to successfully puncture the pericardial membrane. A physicianmay determine the success of puncturing the parietal pericardium 103 bymonitoring the operation and looking for the indication that a testcontrast agent injection flows into the pericardial space 105 asobserved under fluoroscopy imaging.

As previously mentioned, detection of systole may be according tovisual, mechanical, electrical, or any other measurement indicative ofsystole. FIG. 5 is a flowchart for an embodiment of a method ofdetecting systole based on the ECG.

In step S501, ECG is acquired.

According to an embodiment, acquisition of ECG may be according to aconventional method via ECG electrodes, followed by ECG instrumentationand signal processing.

According to another embodiment, acquisition of ECG may be according toconventional ECG electrodes, followed by ECG instrumentation and signalprocessing, and wireless transmission of the ECG signals to acontroller.

According to an embodiment, acquisition of ECG may be according toconventional ECG electrodes, followed by ECG instrumentation and signalprocessing, and fiber optic transmission of the ECG signals to acontroller.

In step S503, a QRS detector is run.

According to an embodiment, detection of QRS may be according to aconventional method of slope detection.

According to another embodiment, detection of QRS may be according to anenvelope or template detection. The envelope or template detection maybe according to a previously acquired QRS, or according to a standardQRS profile or template. The standard QRS profile or template may beadjustable according to one or more of an age, gender, BMI, heart rate,or the presence and nature of an underlying heart disease in a humanpatient.

According to another embodiment, detection of QRS may be according to anextremum detection, such as an R-wave peak detection, a Q-wave minimumdetection, or an S-wave minimum detection. Alternatively, detection ofQRS may include detection of a sequence of extremums, e.g., a Q-waveminimum followed by an R-wave peak, or an R-wave peak followed by anS-wave minimum.

Detection of QRS may be performed in real-time, and with tolerabledelay, such that the detected QRS corresponds to the mechanical activityof the heart in real-time. The tolerable delay between the onset of theQRS complex and the detection of the QRS complex may depend on theduration of systole, and/or the time period between the onset of the QRScomplex and systole.

In step S505, the process checks if QRS is detected. If QRS is notdetected, the process loops back to step S505. Otherwise, the processproceeds to step S507.

In step S507, a timer is started to measure the time elapsed since thedetection of QRS.

In step S509, the process checks if the timer has exceeded apredetermined threshold. The predetermined threshold may be setaccording to an estimate of the duration of time between the detectionof QRS and systole. If the timer has not exceeded the predeterminedthreshold, the process loops back to step S509. Otherwise, the processproceeds to step S511.

According to an embodiment, the predetermined threshold may beadjustable according to one or more of an age, gender, BMI, presence ofunderlying heart disease, or heart rate of a human patient.

In step S511, detection of systole is indicated.

Alternatively, other methods may be used to indicate systole.

According to an embodiment of the present disclosure, a pressuremeasurement may be used to synchronize the process of accessing thepericardial space with systole. The pressure measurement may beperformed at the tip of the needle 107. Alternatively, arterial pressurewave, through an arterial line, or pulse oximetry (plethysmographic)waveform may be used.

The arterial blood pressure indicative of systole may be determined bythe measurement of the arterial blood pressure before the process ofpuncturing the parietal pericardium 103, and adjusting the expectedarterial blood pressure during systole either manually or automatically.As the arterial blood pressure is subject to variation, such measurementmay be updated continually or from time to time, during the process ofpuncturing the parietal pericardium 103.

FIG. 6 is a flowchart for an embodiment of a method of detecting systolebased on a pressure measurement at the tip of the needle 107.

In step S601, a pressure measurement is made at the tip of the needle107.

In step S603, the process checks if pressure has fallen below apredetermined threshold. The predetermined threshold may be setaccording to an estimate of the pressure expected at the tip of theneedle 107 during systole. If the pressure has not fallen below thepredetermined threshold, the process loops back to step S603. Otherwise,the process proceeds to step S605.

According to an embodiment, the predetermined threshold may beadjustable according to one or more of an age, gender, BMI, presence ofunderlying heart disease, or heart rate of a human patient.

In step S605, detection of systole is indicated.

FIG. 7 is a flowchart for an embodiment of a method of detecting systolebased on arterial pressure measurement.

In step S701, an arterial pressure wave is detected. The detection ofthe arterial pressure wave may be through an arterial line, or pulseoximetry waveform may be used.

In step S703, the process checks if the arterial pressure has exceeded apredetermined threshold. The predetermined threshold may be setaccording to an estimate of the arterial pressure during systole. If thearterial pressure has not exceeded a predetermined threshold, theprocess loops back to step S703. Otherwise, the process proceeds to stepS705.

The predetermined threshold may be adjustable according to one or moreof an age, gender, BMI, presence of underlying heart disease, or heartrate of a human patient.

In step S705, detection of systole is indicated.

FIG. 8 is a block diagram of a controller which may be used to performthe above-described processes. A hardware description of the controlleraccording to exemplary embodiments is described with reference to FIG.8. In FIG. 8, the controller includes a CPU 800 which may be used toperform the processes described in the present disclosure. The processdata and instructions corresponding to the processes described in thepresent disclosure may be stored in memory 802. These processes andinstructions may also be stored on a storage medium disk 804 such as ahard drive (HDD) or portable storage medium or may be stored remotely.

Further, the claimed advancements are not limited by the form of thecomputer-readable media on which the instructions of the inventiveprocess are stored. For example, the instructions may be stored on CDs,DVDs, in FLASH memory, RAM, ROM, PROM, EPROM, EEPROM, hard disk or anyother information processing device with which the controllercommunicates, such as a server or computer.

Further, the claimed advancements may be provided as a utilityapplication, background daemon, or component of an operating system, orcombination thereof, executing in conjunction with CPU 800 and anoperating system such as Microsoft Windows 7, UNIX, Solaris, LINUX,Apple MAC-OS and other systems known to those skilled in the art.

CPU 800 may be a Xenon or Core processor from Intel of America or anOpteron processor from AMD of America, or may be other processor typesthat would be recognized by one of ordinary skill in the art.Alternatively, the CPU 800 may be implemented on an FPGA, ASIC, PLD orusing discrete logic circuits, as one of ordinary skill in the art wouldrecognize. Further, CPU 800 may be implemented as multiple processorscooperatively working in parallel to perform the instructions of theinventive processes described in the present disclosure.

The controller in FIG. 8 also includes a network controller 806, such asan Intel Ethernet PRO network interface card from Intel Corporation ofAmerica, for interfacing with network 899. As can be appreciated, thenetwork 899 can be a public network, such as the Internet, or a privatenetwork such as an LAN or WAN network, or any combination thereof andcan also include PSTN or ISDN sub-networks. The network 899 can also bewired, such as an Ethernet network, or can be wireless such as acellular network including EDGE, 3G and 4G wireless cellular systems.The wireless network can also be WiFi, Bluetooth, or any other wirelessform of communication that is known.

The controller further includes a display controller 808, such as aNVIDIA GeForce GTX or Quadro graphics adaptor from NVIDIA Corporation ofAmerica for interfacing with display 810, such as a Hewlett PackardHPL2445w LCD monitor. A general purpose I/O interface 812 interfaceswith a keyboard and/or mouse 814 as well as a touch screen panel 816 onor separate from display 810. General purpose I/O interface alsoconnects to a variety of peripherals 818 including printers andscanners, such as an OfficeJet or DeskJet from Hewlett Packard.

A sound controller 820 is also provided in the controller, such as SoundBlaster X-Fi Titanium from Creative, to interface withspeakers/microphone 822 thereby providing sounds and/or music. Thespeakers/microphone 822 can also be used to accept dictated words ascommands for controlling the controller or for providing location and/orproperty information with respect to the target property.

The general purpose storage controller 824 connects the storage mediumdisk 804 with communication bus 826, which may be an ISA, EISA, VESA,PCI, or similar, for interconnecting all of the components of thecontroller. A description of the general features, detail features, andfunctionality of the display 810, keyboard and/or mouse 814, as well asthe display controller 808, storage controller 824, network controller806, sound controller 820, and general purpose I/O interface 812 isomitted herein for brevity as these features are known.

An ECG data acquisition (DAQ) controller 834 is also provided in thecontroller, to interface with an ECG DAQ 832, so an ECG measurement maybe controlled, displayed and/or recorded via the controller, and used ina process of accessing the pericardial space.

A pressure sensor controller 830 is also provided in the controller, tointerface with a pressure sensor 828, so a pressure measurement may becontrolled, displayed and/or recorded via the controller. The pressuremeasurement may be used in a process of accessing the pericardial space105.

A needle controller 808 is also provided in the controller, to interfacewith the needle 107, so the needle 107 may be controlled via thecontroller.

The disclosed methods make accessing the pericardial space easier andsafer by utilizing the cardiac motion to puncture the parietalpericardium in synchronization with the cardiac motion.

The disclosed methods make accessing the pericardial space easier andsafer by utilizing the cardiac motion to puncture the parietalpericardium in synchronization with that motion.

The disclosed methods may be used to access the pericardial space inorder to deliver drugs to the heart muscle and/or the coronary arteries.Since the pericardial fluid is of relatively low volume, deliveringdrugs via the pericardial fluid requires a relatively lower dose ofdrug.

The disclosed methods may be used to access the pericardial space inorder to introduce an agent into the pericardial space, therebylocalizing the agent to the area around the heart muscle. Such agent isthereby contained within the pericardial fluid, without contaminatingother tissue and/or space. Also, due to the low turn over rate of thepericardial fluid, such agent is sustained over a longer period of time.

The disclosed methods may be used to access the pericardial space inorder to insert a catheter to deliver drugs and/or agents.

The disclosed methods may be used to access the pericardial space inorder to insert a catheter to collect biological tissue or cells.

The disclosed methods may be used to access the pericardial space inorder to insert a catheter into a specific area of the heart to performablation of arrhythmia. Ablation of arrhythmia is performed by directingenergy through a catheter to small areas of the heart muscle that causeabnormal heart rhythm, to disconnect the source of the abnormal rhythmfrom the rest of the heart. This process may also be used to disconnectan abnormal electrical pathway between the atria and the ventricles.

The disclosed methods may be used to access the pericardial space inorder to insert a catheter or tool to ligate the left atrial appendage.

The disclosed methods may be used to access the pericardial space, insituations where a cardiac procedure has led to bleeding into thepericardial space to occur, to insert a catheter to drain blood from thepericardial space until the bleeding source seals on its own, or until asurgical procedure is done to repair it.

The disclosed methods may be used to access the pericardial space, insituations where a disease process has led to the accumulation of bloodor other types of fluid in the pericardial space, to insert a catheterto drain this fluid for diagnostic purposes, and/or relieve the pressureexerted on the heart and improve its function.

The disclosed methods may be used to access the pericardial space, inorder to introduce implantable defibrillator and/or pacemaker electrodesinto the pericardial space.

The disclosed methods may be used under fluoroscopy guidance (X Ray),ultrasound, or CT scan.

The disclosed methods may also be used under magnetic resonance imagingwhen a non-metal needle is used.

Thus, the foregoing discussion discloses and describes merely exemplaryembodiments of the present invention. As will be understood by thoseskilled in the art, the present invention may be embodied in otherspecific forms without departing from the spirit or essentialcharacteristics thereof. Accordingly, the disclosure of the presentinvention is intended to be illustrative, but not limiting of the scopeof the invention, as well as other claims. The disclosure, including anyreadily discernible variants of the teachings herein, define, in part,the scope of the foregoing claim terminology such that no inventivesubject matter is dedicated to the public.

The invention claimed is:
 1. A method for puncturing a pericardialmembrane of a human patient, the method comprising: inserting a needleinto the chest of the human patient; detecting a phase of a mechanicalactivity of the heart of the human patient; advancing the needle towardthe heart of the human patient in synchronization with the detectedphase of the mechanical activity of the heart of the human patient;repeating the detecting and advancing steps until the pericardialmembrane of the human patient is detected and the needle is in contactwith or proximal the percardial membrane; puncturing the pericardialmembrane of the heart of the human patient with an advancement pulse ofthe needle, wherein the advancement pulse is synchronized with a QRScomplex of the heart monitored by electrocardiography, based on a slopeof the electrocardiogram of the human patient corresponding with the QRScomplex; wherein the advancement pulse of the needle is activated by acontroller programmed with instructions to advance a blade of the needlein synchronization with the QRS complex of the heart of the patient. 2.The method of claim 1, wherein the detecting the phase of the mechanicalactivity of the heart of the human patient is based on anelectrocardiogram of the human patient.
 3. The method of claim 2,wherein the detecting the phase of the mechanical activity of the heartof the human patient includes: monitoring the electrocardiogram of thehuman patient to identify the phase of the mechanical activity of theheart of the human patient.
 4. The method of claim 2, wherein thedetecting the phase of the mechanical activity of the heart of the humanpatient further comprises: acquiring the electrocardiogram of the humanpatient; detecting a QRS complex within the electrocardiogram of thehuman patient; waiting for a predetermined time after the detected QRScomplex; and indicating a systole phase of the heart of the humanpatient when the predetermined time after the detected QRS complex haselapsed.
 5. The method of claim 4, further including: adjusting thepredetermined time based on at least one of an age, a gender, a heartrate, a presence of an underlying heart disease, or a body mass index ofthe human patient.
 6. The method of claim 4, wherein the detecting theQRS complex within the electrocardiogram of the human patient includes:determining a correlation between a time window of the electrocardiogramof the human patient and a predetermined QRS template; and determiningif the determined correlation has exceeded a predetermined correlationthreshold.
 7. The method of claim 6, further including: determining thepredetermined QRS template based on a previously acquired QRS complex ofthe human patient.
 8. The method of claim 1, wherein the detecting thephase of the mechanical activity of the heart of the human patientincludes: measuring a pressure at the tip of the needle; determining ifthe measured pressure has fallen below a predetermined pressurethreshold.
 9. The method of claim 8, further including: adjusting thepredetermined pressure threshold based on at least one of an age, agender, a heart rate, a presence of an underlying heart disease, or abody mass index of the human patient.
 10. The method of claim 1, whereinthe detecting the phase of the mechanical activity of the heart of thehuman patient includes: measuring an arterial pressure of the humanpatient; determining if the measured arterial pressure has exceeded apredetermined arterial pressure threshold.
 11. The method of claim 10,further including: adjusting the predetermined arterial pressurethreshold based on at least one of an age, a gender, a heart rate, apresence of an underlying heart disease, or a body mass index of thehuman patient.
 12. The method of claim 1, further comprising: injectinga contrast agent from the tip of the needle; and determining that thepericardial membrane is punctured when the contrast agent is seen in thepericardial space.